Invasive treatments for obesity are often recommended for patients with a body mass index (mass/height2 [kg/m2]) which is greater than 35 or 40. For such patients, their weight is commonly associated with increased risk of heart disease, diabetes, and arthritis. Preferably, the invasive treatments are accompanied by changes in lifestyle, such as improved eating habits and an appropriate exercise regimen.
U.S. patent application Ser. No. 09/734,358 to Flesler et al., which published as U.S. Patent Application Publication 2002/0161414, and which is assigned to the assignee of the present patent application and is incorporated herein by reference, describes apparatus for treating a condition such as obesity. The apparatus includes a set of one or more electrodes, which are adapted to be applied to one or more respective sites in a vicinity of a body of a stomach of a patient. A control unit is adapted to drive the electrode set to apply to the body of the stomach a signal, configured such that application thereof increases a level of contraction of muscle tissue of the body of the stomach, and decreases a cross-sectional area of a portion of the body of the stomach for a substantially continuous period greater than about 3 seconds.
PCT Publication WO 02/082968 to Policker et al., which is assigned to the assignee of the present application and is incorporated herein by reference, describes a diet evaluation gastric apparatus, which detects when a patient swallows, and detects the type and amount of matter ingested. The apparatus includes electrodes adapted to be coupled to the fundus and antrum of the patient and to measure electrical and mechanical activity therein, and a control unit to analyze such electrical and mechanical activity and optionally apply electrical energy to modify the activity of tissue of the patient.
PCT Publication WO 02/053093 to Policker et al., which is assigned to the assignee of the present application and is incorporated herein by reference, describes a method for treating a subject, including receiving a sensor signal responsive to the subject eating, analyzing the sensor signal, and driving a current into tissue of the subject responsive to analyzing the signal. The current is typically driven into muscle tissue of the subject's stomach. Typically, receiving the sensor signal includes sensing electrical potential change generated responsive to contraction of a muscle such as a stomach muscle of the subject.
U.S. Pat. No. 5,690,691 to Chen et al., which is incorporated herein by reference, describes a gastric pacemaker for treating obesity and other conditions. The pacemaker includes multiple electrodes which are placed at various positions on the gastrointestinal (GI) tract, and which deliver phased electrical stimulation to pace peristaltic movement of material through the GI tract.
U.S. Pat. No. 6,243,607 to Mintchev et al., which is incorporated herein by reference, describes a gastrointestinal electrical pacemaker, including multiple electrodes which are arranged around a portion of the GI tract. The electrodes stimulate smooth muscle so that local contractions of the portion of the GI tract are artificially propagated therethrough, in order to facilitate a partial emptying of the portion. Preferably, the local contractions are artificially propagated by phase locking or time shifting the electrical stimulus, which is applied to the smooth muscle circumferentially about the portion at two or more locations.
U.S. Pat. No. 5,423,872 to Cigaina, which is incorporated herein by reference, describes apparatus for applying electrical pulses to the distal gastric antrum of a patient, so as to reduce the motility of the stomach and to thereby treat obesity or another condition.
U.S. Pat. No. 5,231,988 to Wernicke et al., which is incorporated herein by reference, describes techniques for treating and controlling diabetes and other systemic pancreatic endocrine disorders attributable to abnormal levels of secretion of endogenous insulin. An electrical stimulator implanted into or worn external to the patient's body is adapted, when activated, to generate a programmable electrical waveform for application to electrodes implanted on the vagus nerve of the patient. The electrical waveform is programmed using parameter values selected to stimulate or inhibit the vagus nerve to modulate the electrical activity thereof to increase or decrease secretion of natural insulin by the patient's pancreas. The stimulator is selectively activated manually by the patient in response to direct measurement of blood glucose or symptoms, or is activated automatically by programming the activation to occur at predetermined times and for predetermined intervals during the circadian cycle of the patient. Alternatively, the automatic activation is achieved using an implanted sensor to detect the blood glucose concentration, and is triggered when the patient's blood glucose concentration exceeds or falls below a predetermined level depending on whether diabetes or hypoglycemia is being treated.
U.S. Pat. Nos. 5,188,104 and 5,263,480 to Wemicke et al., which are incorporated herein by reference, describe a method for stimulating the vagus nerve of a patient so as to alleviate an eating disorder.
U.S. Pat. Nos. 6,104,955, 6,091,992, and 5,836,994 to Bourgeois, U.S. Pat. No. 6,026,326 to Bardy, and U.S. Pat. No. 3,411,507 to Wingrove, which are incorporated herein by reference, describe the application of electrical signals to the GI tract to treat various physiological disorders.
PCT Patent Publication WO 99/03533 to Ben-Haim et al., entitled, “Smooth muscle controller,” and U.S. patent application Ser. No. 09/481,253 in the national phase thereof, both of which are assigned to the assignee of the present patent application and are incorporated herein by reference, describe apparatus and methods for applying signals to smooth muscle so as to modify the behavior thereof. In particular, apparatus for controlling the stomach is described in which a controller applies an electrical field to electrodes on the stomach wall so as to modify the reaction of muscle tissue therein to an activation signal, while not generating a propagating action potential in the tissue. In the context of the present patent application and in the claims, the use of such a non-excitatory signal to modify the response of one or more cells to electrical activation thereof, without inducing action potentials in the cells, is referred to as Excitable-Tissue Control (ETC). Use of an ETC signal is described with respect to treating obesity, by applying the ETC signal to the stomach so as to delay or prevent emptying of the stomach. In addition, a method is described for increasing the motility of the gastrointestinal tract, by applying an ETC signal to a portion of the tract in order to increase the contraction force generated in the portion.
U.S. Pat. No. 6,317,631 to Ben-Haim et al., which is assigned to the assignee of the present patent application and is incorporated herein by reference, describes methods for modifying the force of contraction of a heart chamber by applying an ETC signal to the heart.
U.S. Pat. No. 5,716,385 to Mittal et al., which is incorporated herein by reference, describes a crural diaphragm pacemaker for treating gastroesophageal reflux. The pacemaker includes one or more electrodes which are placed in contact with the crural diaphragm, either by implantation or by connecting the electrodes to the skeletal muscles of the crural diaphragm through the skin. During spontaneous intermittent relaxations of the diaphragm, the electrodes stimulate the skeletal muscles of the crural diaphragm, in order to cause contraction of the lower esophageal sphincter.
U.S. Pat. No. 6,535,764 to Imran et al., which is incorporated herein by reference, describes techniques for diagnosing and treating gastric disorders. A functional device resides within the patient's stomach and is secured to the stomach wall by an attachment device. The functional device may be a sensor for sensing various parameters of the stomach or stomach environment, or may be a therapeutic delivery device. The functional device in one embodiment comprises stimulating electrodes for gastric electrical stimulation.
U.S. Pat. No. 4,696,288 to Kuzmak et al., which is incorporated herein by reference, describes calibrating apparatus adapted to be inserted into and proceeded within the stomach of human body.
U.S. Pat. No. 4,592,339 to Kuzmak et al., which is incorporated herein by reference, describes a gastric band for forming a stoma opening in a stomach for treating morbid obesity. The band is invasively placed around the stomach, and an expandable portion of the band is used to adjust the diameter of the stoma opening.
U.S. Pat. Nos. 5,449,368, 5,226,429, and 5,074,868 to Kuzmak, which are incorporated herein by reference, describe adjustable gastric bands. The size of the stoma opening of the bands can be adjusted by injecting into or removing fluid from an expandable section of the gastric bands.
U.S. Pat. No. 5,601,604 to Vincent, which is incorporated herein by reference, describes a gastric band for placement around the stomach for treating morbid obesity. The inner surface of the band is inflatable through a remote fill port. The band is invasively placed in an encircling position around the stomach by the facile closure of a single fastening means. After the band is fastened around the stomach, a fluid is injected into the inflatable inner surface, thereby constricting the stoma of the stomach.
U.S. Pat. No. 5,658,298 to Vincent et al., which is incorporated herein by reference, describes a tool for tightening a band or ligature having a buckle end and a free end during laparoscopic surgery.
PCT Publication WO 01/83019 to Vincent, which is incorporated herein by reference, describes apparatus and methods for transferring particles and fluids to or from a body of a patient, including inflating a balloon inside the body during surgical procedures to facilitate the identification of anatomical landmarks and to provide guidance for surgical dissections.
U.S. Pat. No. 5,938,669 to Klaiber et al., which is incorporated herein by reference, describes an adjustable gastric band for contracting a patient's stomach in order to fight obesity. A gastric band of a known type, implanted around the stomach and including a cavity filled with liquid, is connected by a tube to a control box and a balancing reservoir which are implanted under the skin of the patient. The box contains an electric pump and an electronic control unit capable of communicating by radio with a monitor carried by the patient and with a controller intended for the doctor. The controller can operate the pump by remote control to transfer determined volumes of liquid in a closed circuit from the gastric band to the reservoir or vice versa, to adjust the diameter of a passage in the stomach. The monitor receives and signals alarms from the control box.
U.S. Pat. No. 6,067,991 to Forsell, which is incorporated herein by reference, describes an adjustable gastric band including an elongated non-inflatable restriction member, a forming device for forming the restriction member into at least a substantially closed loop around the stomach or the esophagus to define a restriction opening, and a post-operation non-invasive adjustment device for mechanically adjusting the restriction member in the loop to change the size of the restriction opening.
U.S. Pat. No. 6,210,347 to Forsell, which is incorporated herein by reference, describes a food intake restriction device for forming a stoma opening in the stomach or esophagus of a patient.
U.S. Pat. No. 6,460,543 to Forsell, which is incorporated herein by reference, describes a food intake restriction device for forming a stoma opening in the stomach or esophagus of a patient.
U.S. Pat. No. 6,453,907 to Forsell which is incorporated herein by reference, describes an adjustable gastric band that includes an energy transmission device for wireless transmission of energy of a first form from outside the body of the patient.
U.S. Pat. No. 6,454,699 to Forsell, which is incorporated herein by reference, describes food intake restriction apparatus that includes a restriction device implanted in a patient, which engages the stomach or esophagus to form an upper pouch and a restricted stoma opening in the stomach or esophagus.
U.S. Patent Application Publication 2003/0066536 to Forsell, which is incorporated herein by reference, describes food intake restriction apparatus, including an operable restriction device implanted in a patient and engaging the stomach or esophagus to form a restricted stoma opening in the stomach or esophagus.
U.S. Patent Application Publication 2001/0011543 to Forsell, which is incorporated herein by reference, describes apparatus for treating morbid obesity or heartburn and reflux disease, including an elongated restriction member formed in a substantially closed loop around a stomach or esophagus of a human to form a stoma opening in the stomach or esophagus.
PCT Publication WO 01/41671 to Cigaina, which is incorporated herein by reference, describes a removable gastric band for controlling obesity by allowing control and/or modification of the diameter of a stomach of a patient. The gastric band comprises a closure mechanism, which allows the elongated body to close around a portion of the stomach. The gastric band can be used in conjunction with a gastric electrostimulator, and is therefore described as being potentially useful for inducing forced slimming in the initial phase of treatment for morbigenous obesity. Such electrostimulation devices may either be incorporated into the removable gastric band or located at a distance from the removable gastric band.
European Patent Application Publication 1 036 545 A2 to Moshe, which is incorporated herein by reference, describes a gastric band for attaching around a circumference of a stomach of a patient, so as to define the diameter of the stomach opening.
U.S. Pat. No. 6,511,490 to Robert, which is incorporated herein by reference, describes a gastric banding device for implantation within a person for the treatment of morbid obesity. The gastric banding device includes an inflatable band portion dimensioned to encircle the stomach, and an inflation conduit operable for conducting a percutaneously injected inflation fluid into the band portion.
U.S. Pat. No. 6,547,801 to Dargent et al., which is incorporated herein by reference, describes an implantable gastric constriction device comprising a constriction member forming a ring in its operational configuration.
U.S. Pat. No. 5,259,399 to Brown, which is incorporated herein by reference, describes a method and apparatus for causing weight loss in obese patients by occupying a segment of the stomach volume using a variable volume bladder filled with fluid.
U.S. Pat. No. 5,234,454 to Bangs, which is incorporated herein by reference, describes a method for controlling the body weight of a patient.
U.S. Pat. No. 4,416,267 to Garren et al., which is incorporated herein by reference, describes a stomach insert for treating obesity in humans by reducing the stomach volume.
U.S. Pat. No. 6,454,785 to De Hoyos Garza, which is incorporated herein by reference, describes a percutaneous intragastric balloon catheter for the treatment of obesity. The balloon is non-surgically placed in the stomach, and is collocated by percutaneous endoscopic gastrostomy (PEG). The balloon includes a valve for regulating the amount of fluid introduced or evacuated from the balloon.
INAMED Corporation (Santa Barbara, Calif.) manufactures and markets the LAP-BAND® System, an FDA-approved adjustable and reversible gastric band for treatment of obesity.
Glucagon-like-peptide-1 (GLP-1) is a known modulator of insulin secretion in the early phases of a meal and a mediator of satiety. In response to ingestion of a meal, GLP-1 is secreted into the blood by L-cells mainly located in the colon and distal small intestine. Administration of GLP-1, either subcutaneously or peripherally, has been shown to improve glycemic control, partially by restoring the first-phase insulin response and suppressing glucagon, and is therefore considered a potential treatment for obesity and Non-Insulin Dependent Diabetes Mellitus (NIDDM).
Todd J F et al., in an article entitled, “Glucagon-like peptide-1 (GLP-1): a trial of treatment in non-insulin-dependent diabetes mellitus,” Eur J Clin Invest 27(6):533-6 (1997), which is incorporated herein by reference, write that “GLP-1 has the advantages of both suppressing glucagon secretion and delaying gastric emptying.” They conclude, “GLP-1 improves glycaemic control even in the absence of an insulinotropic effect and is a potential treatment for NIDDM.”
U.S. Pat. No. 6,191,102 to DiMarchi et al., which is incorporated herein by reference, describes pharmaceutical compositions comprising a glucagon-like peptide-1 compound for reducing body weight and treating obesity. The compositions are peripherally administered.
Luiken et al., in an article entitled, “Contraction-induced fatty acid translocase/CD36 translocation in rat cardiac myocytes is mediated through AMP-activated protein kinase signaling,” Diabetes, July, 2003, 52(7):1627-34, which is incorporated herein by reference, write that contraction of rat cardiac myocytes induces translocation of fatty acid translocase (FAT)/CD36 and GLUT4 from intracellular stores to the sarcolemma, leading to enhanced rates of long-chain fatty acid (FA) and glucose uptake, respectively. Luiken et al. note that because intracellular AMP/ATP is elevated in contracting cardiac myocytes, they investigated whether activation of AMP-activated protein kinase (AMP kinase) is involved in contraction-inducible FAT/CD36 translocation. The cell-permeable adenosine analog 5-aminoimidazole-4-carboxamide-1-beta-D-ribofuranoside (AICAR) and the mitochondrial inhibitor oligomycin, similar to 4-Hz electrostimulation, are described as evoking a more than threefold activation of cardiomyocytic AMP kinase. Both AICAR and oligomycin are described as stimulating FA uptake into noncontracting myocytes by 1.4- and 2.0-fold, respectively, but ineffective in 4 Hz-contracting myocytes. These findings are interpreted to indicate that both agents stimulate FA uptake by a similar mechanism as electrostimulation, involving activation of AMP kinase, as evidenced from phosphorylation of acetyl-CoA carboxylase. Furthermore, the stimulating effects of both AICAR and oligomycin were reported as being antagonized by blocking FAT/CD36 with sulfo-N-succinimidylpalmitate, but not by inhibiting phosphatidylinositol 3-kinase with wortmannin, indicating the involvement of FAT/CD36, but excluding a role for insulin signaling. Subcellular fractionation showed that oligomycin was able to mobilize intracellularly stored FAT/CD36 to the sarcolemma. Luiken et al. conclude that AMP kinase regulates-cardiac FA use through mobilization of FAT/CD36 from a contraction-inducible intracellular storage compartment.
The following articles, which are incorporated herein by reference, may be of interest:    Gutniak M K et al., “Subcutaneous injection of the incretin hormone glucagon-like peptide 1 abolishes postprandial glycemia in NIDDM,” Diabetes Care 17(9):1039-44 (1994)    Robertson M D et al., “The influence of the colon on postprandial glucagon-like peptide 1 (7-36) amide concentration in man,” J Endocrinol 161(1):25-31 (1999)    Schirra J et al., “Mechanisms of the antidiabetic action of subcutaneous glucagon-like peptide-1 (7-36) amide in non-insulin dependent diabetes mellitus,” J Endocrinol 156(1):177-86 (1998)    Todd J F et al., “Subcutaneous glucagon-like peptide-1 improves postprandial glycaemic control over a 3-week period in patients with early type 2 diabetes,” Clin Sci (Lond) 95(3):325-9 (1998).    Vilsboll T et al., “Reduced postprandial concentrations of intact biologically active glucagon-like peptide 1 in type 2 diabetic patients,” Diabetes 50(3):609-13 (2001)